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introductionExpress Scripts Drug Trend Report 2004 Introduction
KEY EVENTS ON THE 2004 PHARMACY LANDSCAPE
Even though prescription-drug spending was up again in 2004, the year’slone major gain for pharmaceuticals was more than offset by losses.
• In one of the year’s few bright spots for the pharmaceutical industry, the overall utilization of cholesterol-lowering drugs known as statinsincreased by 12% in 200410 — boosted in large part by updatedclinical guidelines that recommend reduced goal levels of low-densitylipoproteins (LDL) for high-risk patients. In general, however, 2004 was a year of significant problems, not onlyfor the pharmaceutical industry but also for the U.S. Food and DrugAdministration (FDA).
• Voluntary removal of Vioxx® from the world market in September 2004 and its later reintroduction in some countries focused attentionon the prescription-drug approval process in the U.S. Along withother drugs in the COX-2 subclass, Vioxx was advertised heavily in direct-to-consumer (DTC) ads following its U.S. introduction in1999. Particular emphasis was placed on the stomach-protective effectof COX-2s. However, subsequent research found that individualswho take Vioxx for 18 months or longer are at increased risk forheart attacks and strokes. In December 2004, concerns spread toinclude all COX-2s after additional information linked Celebrex®and Bextra® to health problems similar to those seen with Vioxx. As a result, U.S. prescriptions for COX-2s dropped from about 4.5 million to about 2.7 million in the last three months of2004.11 While an FDA decision in February 2005 allowed someCOX-2s to stay on the market, the manufacturer of Bextra suspendedits sales in early April after a request for its withdrawal from theFDA. A black-box warning is now required on the labels of allCOX-2s still sold in this country. DTC advertising for them hasbeen eliminated, and COX-2 utilization is expected to stay relativelylow since physicians are being advised to prescribe them in lowerdoses and for shorter lengths of time. 10 IMS Health. 2004 Year-End U.S. Prescription and Sales Information and Commentary. No date given. Available at: http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_18731_69890098,00.html. Accessed February 25, 2005.
11 IMS Health. 2004 Year-End U.S. Prescription and Sales Information and Commentary. No date given. Available at: http://www.imshealth.com/ims/portal/front/articleC/0,2777,6599_18731_69890098,00.html. Accessed February 25, 2005.
• An FDA advisory in October 2004 addressed issues raised earlier about the use of antidepressants for children and teens. Researchthat linked suicide attempts and suicidal thoughts among pediatricand adolescent patients to treatment with antidepressant drugs led to both a warning label on all antidepressants and a decrease in antidepressant use among patients aged 18 years and younger.12 • Newer, second-generation (atypical) antipsychotic drugs have been associated with higher risks of developing diabetes, high cholesteroland obesity. Early in 2004, four major medical societies, includingthe American Diabetes Association and the American PsychiatricAssociation, recommended more frequent and extensive health testingfor patients taking a second-generation antipsychotic medication. As a result, expenses on the medical side are expected to increase for these patients.
Recent negative press about prescription drugs is likely to cause changesin the drug-approval process. In February 2005, the FDA announcedplans to establish a Drug Safety Oversight Board. The board, consistingof FDA employees and medical personnel from other federal agencies,will consult with independent experts and patients. In addition to postingsafety information on a new Drug Watch Web site, the board will alsowork to improve the printed drug information patients receive with theirprescriptions. Additionally, the FDA has stated plans to make its reviewand decision-making processes more independent and transparent.13Problems with drug safety may also lead to more stringent requirementsfor clinical trials, slower approval times and less chance of approval for me-too drugs. Another result of the pharmaceutical industry’s recent challenges is a newdrive to establish a clinical trials registry. Despite some manufacturercomplaints that making their trials public will give competitors unfairadvantages, several have set up their own trial-information Web sites. 12 Center for Drug Evaluation and Research. U.S. Food and Drug Administration. FDA Public Health Advisory. Suicidality in children and adolescents being treated with antidepressant medications. October 15, 2004. Available at: http://www.fda.gov/cder/drug/antidepressants/SSRIPHA200410.htm. Accessed March 11, 2005.
13 U.S. Food and Drug Administration. FDA Fact Sheet. FDA improvements in drug safety monitoring. February 15, 2005.
Available at: http://www.fda.gov/oc/factsheets/drugsafety.html. Accessed February 15, 2005.
12 express scripts drug trend report 2004
However, the medical establishment favors an independent repository (such as www.clinicaltrials.gov), which is designed to discourage selectivereporting from drug trials and other medical studies. Although trial registration in an independent database is voluntary at this time, theInternational Committee of Medical Journal Editors has put pressure onpharmaceutical companies to comply. The group, which includes editorsof major medical journals such as the Annals of Internal Medicine, theJournal of the American Medical Association, Lancet and the New EnglandJournal of Medicine, instituted a new policy in 2004. These editors havestated that effective July 1, 2005, they will not accept for considerationstudy results that have not been registered in an independent databasebefore patient enrollment begins. According to the group’s criteria, theregistry must be comprehensive, free, public, maintained by a nonprofitentity and open to all clinical investigators. In addition, it must have a mechanism for validating information, and readers must be able to search the contents electronically.
Dilemmas for the FDA and the pharmaceutical industry were not theonly prescription-related issues that made news in 2004. Other dramaticdevelopments may affect prescription-drug benefits for years to come. On the supply side, drug reimportation from Canada and other countries isan ongoing issue. One increasing concern with reimports is the potentialfor counterfeited drugs, a long-standing problem in many parts of theworld. Estimated to affect about 10% of the world’s prescription-drugsupply, drug counterfeiting recently has become more visible in theU.S. The number of counterfeit drug cases investigated by the FDAincreased from five in 2000 to 21 in 2003.14 In another area of rising concern, supplies of certain vaccines and some other drugs have beeninadequate to meet current needs.15 On the policy side, federal budget cuts threaten to eliminate significant amounts of drug coverage underMedicaid — at the same time that Medicare reform will provide prescription-drug benefits for millions of seniors.
14 Cockburn R, Newton PN, Agyarko E, Akunyili D, White NJ (2005). The Global Threat of Counterfeit Drugs: Why Industry and Governments Must Communicate the Dangers. PLoS Medicine 2(4): e100. Available at: http://www.plosmedicine.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020100. 15 Marcus AD. Critical cancer drug faces shortage. The Wall Street Journal. March 15, 2005. Page D1.
MEDICARE MODERNIZATION ACT (MMA)
The Medicare Prescription Drug, Improvement, and Modernization
Act of 2003 (MMA) is the most significant recent development affecting
prescription-drug coverage in the U.S. MMA expands services for
Medicare beneficiaries. Among its major provisions is Part D, whichoffers Medicare enrollees an optional outpatient prescription-drug benefit that is being implemented in two phases. Beginning in May 2004, enrolleeswere offered the choice of several prescription discount-card options.
These discount programs remain active until either May 15, 2006, or thedate that the beneficiary enrolls in a Part D plan, whichever is earlier. Theinterim cards provide up to an estimated 25% discount on prescription-drug purchases.16 The full-scale drug-benefit program will go into effecton Jan. 1, 2006. Under Medicare Part D, services will be provided by private plans that will assume some financial risk for the programs. Exhibit 5
Summary of Medicare Benefits
ALSO KNOWN AS
ENROLLMENT
BENEFICIARIES
COVERAGE
As shown in Exhibit 6, prescription-drug coverage under Medicare Part D is complex. It includes a monthly premium, a deductible, a copayment for partial coverage up to a specified dollar amount, an out-of-pocket period (the so-called “donut hole”), and then 95% coverage for expenses over a specified amount. 16 Centers for Medicare & Medicaid Services. Overview. Medicare prescription drug discount card and transitional assistance program. Last modified September 16, 2004. Available at: http://www.cms.hhs.gov/discountdrugs/overview.asp. 14 express scripts drug trend report 2004
Exhibit 6
Medicare Part D Prescription-Drug Coverage 2006
Defined Standard Benefit*
TOTAL DRUG COST
MEDICARE PAYS
ENROLLEE PAYS**
OUT-OF-POCKET COST TO ENROLLEE
* The defined standard benefit is the basic plan as outlined in the MMA. Plan sponsors may offer alternative benefits that provide equal or greater value to plan participants.
** Adapted from: Centers for Medicare & Medicaid Services. Alternative part D benefit designs and options for enhancing medicare drug coverage.
Issue paper #31. January 19, 2005. Available at: http://www.cms.hhs.gov/medicarereform/issuepapers/title1and2/issue_paper_31_alternative_part_d_benefit_designs_and_options_for_enhancing_medicare_drug_coverage_.pdf. Accessed April 27, 2005.
Individuals eligible for Medicare Part A are also eligible for Part D.
Enrollee contributions will be adjusted on an annual basis. Initial costsfor each enrollee are shown in Exhibit 7, along with estimates of costsfor 2015. Exhibit 7
Medicare Part D Enrollee Contributions
Sources: Connolly C, Allen M. Medicare drug benefit may cost $1.2 trillion. Washington Post. February 9, 2005; Page A01; and A detailed descriptionof CBO’s cost estimate for the Medicare prescription drug benefit. The Congressional Budget Office. July 2004. Available at: http://www.cbo.gov/ftp-docs/56xx/doc5668/Report.pdf. Accessed February 9, 2005.
Plans that provide Medicare prescription-drug coverage will serve specifiedgeographical regions. Enrollees who opt for drug coverage will have thechoice of joining an integrated medical and prescription-drug plan(Medicare Advantage, also known as an MA-PD); or joining a prescription-drug only plan (PDP). Enrollees in each Medicare-defined region will be able to choose from at least two plans, one of which must be a PDP. The Congressional Budget Office estimates that around three-quarters ofMedicare Part B enrollees will also participate in Part D, with about one-fifth staying in employer-sponsored plans and the remaining individualschoosing either alternate forms of prescription insurance or no coverage.17 17 A detailed description of CBO’s cost estimate for the Medicare prescription drug benefit. The Congressional Budget Office.
July 2004. Available at: http://www.cbo.gov/ftpdocs/56xx/doc5668/Report.pdf. Accessed February 9, 2005.
Retirees cannot receive both Medicare Part D and prescription-drug coverage that is completely employer-sponsored. To reduce the possibilitythat employers might simply drop coverage for retirees when Part Dbecomes fully operational, MMA also provides incentives to companies that continue providing drug coverage.18,19 Options that employers may choose include: • Maintaining the current plan and receiving a tax-free government subsidy to reimburse 28% of permitted drug costs for eachMedicare-eligible retiree who does not enroll in Part D. The planoffered by the employer must be at least equivalent to Part D, and the subsidy will be capped at a maximum amount.
• Adapting the existing drug benefit to coordinate with (or wrap-around) Part D — probably by covering some Part D copayments anddeductibles for retirees who choose to enroll in Part D.
• Paying the monthly premiums for eligible retirees who choose Part D.
• Contracting for prescription-drug coverage from a third-party PDP or MA-PD, or becoming a PDP or MA-PD.
As part of MMA, plans that provide Part D prescription-drug benefitswill be required to support e-prescribing. Sending electronic prescriptionsdirectly from the prescribing physician to the dispensing pharmacy addsextra dimensions of safety. Difficult-to-read handwriting is eliminated, andchances for alteration or loss of the prescription are minimized. Commonaccess to the patient’s prescription history also allows automatic checks for allergies, drug interactions and duplicate therapy at the point of prescribing, as well as at the dispensing pharmacy. Private efforts are under way to accelerate the adoption of both e-prescribingand the use of electronic medical records — a priority issue for the currentadministration. Two organizations already exist to facilitate e-prescribing:RxHub®, a joint effort of the three largest pharmacy benefit managers(PBMs), which handles the electronic transfer of information among 18 Deloitte. Employer response to Medicare part D prescription drugs — 2005 survey. BenefitsLink. January 10, 2005. Available at: http://www.benefitslink.com/articles/deloitte_part_d_survey.pdf. Accessed February 8, 2005.
19 Bakich K. Medicare prescription drug law requires new disclosures for retiree health plans. Employee Benefit News. 16 express scripts drug trend report 2004
physician offices, pharmacies and PBMs; and SureScripts, a similar company founded by the National Association of Chain Drug Stores(NACDS) and the National Community Pharmacists Association (NCPA).
Additionally, America’s big three car manufacturers — Chrysler, Fordand General Motors — announced in February 2005 their alliance withthe three biggest healthcare insurers in Michigan. The car makers andthe health plans hope to recruit as many as 17,000 physicians willing to initiate e-prescribing systems funded by the companies, as allowed in the MMA.20 On the public-policy side, the U.S. Departments of Defense, VeteransAffairs, and Health and Human Services announced a collaboration in March 2005. Together, they will create a common set of standards for information-sharing among the health programs — includingMedicare — that they oversee. Eight high-technology companies areworking with the government to implement guidelines that will assurecompatibility among computer systems and software. The new policiesare set to take effect concurrently with the full-scale implementation of Medicare Part D prescription-drug coverage on Jan. 1, 2006.
PLAN ACTIONS
Even though the pharmaceutical landscape changed dramatically
in 2004, many plan sponsors were able to manage prescription-drug
trend. Plan sponsors most successful in controlling trend use a number
of different programs that control costs while still preserving adequate
coverage. Three-tier formulary programs remain popular, and nearly
70% of Express Scripts clients were using a three-tier formulary by
the end of 2004. In a three-tier formulary, generic drugs are covered
at the lowest copayment, formulary brands at a higher amount and
nonformulary brands at the highest copayment. Among Express Scripts
clients, more than 18% are now using Generics Preferred, our mandatory-
generic plan design. An additional 49% use a restricted generic policy —
Generics Preferred-Physician’s Choice — which does not require the
member to pay a higher amount if the doctor orders a brand drug.
20 Porretto J. Wagoner: Medical costs huge competitive disadvantage. Miami Herald. February 10, 2005.
While formularies are the cornerstone of pharmacy-benefit design, the strategies that best control trend incorporate a variety of programs —all aimed at improving generic penetration. Generic-drug costs averageapproximately $45 less than brand costs, and member copayments for generics average $10 less than brand copayments.21 Trend programs shouldnot be implemented abruptly, however. A phase-in approach, which adds programs over a multi-year time frame and uses frequent communications,minimizes member disruption. In addition, Express Scripts recommendsthat plan sponsors develop a trend strategy that gives members confidencein the continuing ability to afford maintenance drugs. Plan sponsors areadvised to set overall member financial contributions between 20% and 35% of drug-ingredient cost.
Generic utilization can be driven by the use of home delivery for maintenance drugs. Across the Express Scripts book of business, eachmaintenance prescription filled through home delivery costs up to 10% less than the equivalent prescription filled at a local participating(retail) pharmacy. Exclusive Home Delivery, our mandatory-mail program,focuses on drugs that are appropriate for home delivery and results in totalaverage savings of approximately $35 per member per year (PMPY).
Many Express Scripts clients that initiated step-therapy programs during 2003 added more modules throughout 2004, and more clientsadopted at least one step-therapy module. By the end of the year, morethan 13 million members were enrolled in step-therapy plans, using anaverage of seven step-therapy modules. Each module focuses on appropriateutilization in one therapy class (such as antihypertensives) or subclass(such as non-sedating antihistamines). By implementing all the step-therapymodules that Express Scripts offers, some clients have saved 10% or moreof overall drug spend through greater generic penetration.
For specific types of drug-delivery systems (such as eye drops or inhalers)that contain measured amounts of drugs or specific numbers of doses,quantity limits ensure that the amount of medication supplied is consistentwith both clinical dosing guidelines and the plan sponsor’s benefit design.
21 Geographic variations in generic fill rate. Express Scripts. No date given. Available at: http://www.express-scripts.com/ ourcompany/news/outcomesresearch/onlinepublications/regionalgenericvariation/regionalgenericvariation.pdf. 18 express scripts drug trend report 2004
As detailed in the Pharmacy Benefit Guide section, quantity limits also help prevent billing errors. As part of the Drug Quantity Managementprogram, Express Scripts also offers concurrent dose consolidation,which recommends a single unit of one drug strength in place of twounits that are half that strength when the price for different strengths is similar. The recommendation is relayed to the dispensing pharmacyon the first fill of a new prescription. Some research has touted large savings from retrospective dose consolidation (using prescription claimsto identify dose-consolidation opportunities after the prescription hasbeen filled). Express Scripts researchers, however, found savings of only$0.02 to $0.03 per member per month (PMPM) for a retrospective dose-consolidation program after savings were calculated using realistic,partial-compliance rates and before administrative costs were considered.22This research article received the Journal of Managed Care Pharmacy’sPaper of the Year Award for 2004. Client interest in newer and developing plan designs is also increasing.
For example, as today’s consumers are becoming more prepared to participate in healthcare decisions, plan sponsors are recognizing thatits members can take more responsibility for those decisions. As a result,consumer-driven healthcare is receiving renewed attention. ExpressChoiceSM (Express Scripts’ consumer-oriented plan design) allows plansponsors to offer multiple prescription-drug plans with varying degreesof management. Each member selects the most appropriate plan for hisor her given situation. Those who choose more tightly-managed plandesigns pay the lowest premiums and copayments, while those whoselect a richer benefit have higher associated costs. For the more than 2 million members enrolled in Express Choice, the result has been a significant reduction in drug spend while maintaining strong member satisfaction.
22 Delate T, Fairman KA, Carey SM, Motheral BR. Randomized controlled trial of a dose consolidation program. Journal of Managed Care Pharmacy. 2004;10(5):396-403. TRENDS IN EXPENDITURES FOR PRESCRIPTION DRUGS
Express Scripts clients that used any trend-management program saw
a trend increase of 9.3% in 2004. However, those implementing one
or more programs for the first time in 2004 saw an average increase
of only 3.3%, and those implementing two or more programs had no increase in drug spend (Exhibit 8). Exhibit 8
Net Drug Trend From 2003 to 2004
MARKET TRENDS IN PRESCRIPTION-DRUG USE
In 2004, prescription-drug costs were affected by many of the same
issues that influenced costs in 2003. Movement of key drugs to over-
the-counter (OTC) status continued to affect the cost of antihistamines,
cough and cold products, and gastrointestinals. This trend is not expected
to abate as new strengths of products already available OTC continue
to flood the market. Completely new products, never before available
without prescriptions, are also expected to enter the OTC market
within the next few years.
The second continuing trend was the increasing availability of genericalternatives to blockbuster brand drugs. By the end of the fourth quarter of 2004, trend-management programs implemented by Express Scriptsclients also helped drive the generic fill rate to 52.7% for the Express Scriptsbook of business.
The third and potentially most significant issue affecting 2004 drugtrend was the body of evidence showing that the long-term side effectsof several classes or subclasses of drugs exceeded their treatment benefits.
In 2004, information regarding the safety of COX-2 inhibitors led to the withdrawal of Vioxx from the market. Subsequently, utilization 20 express scripts drug trend report 2004
of other COX-2s declined. Exhibit 9 shows the monthly cost of COX-2s and NSAIDs among Express Scripts clients in 2004. When examined on a quarterly basis, costs for the entire class were down 10.5% in thefourth quarter compared with the first-quarter baseline.
Exhibit 9
Change in COX-2 and NSAID Prescriptions PMPM
January 2003 to December 2004
Antidepressants also took a hit late in 2004 when the FDA issued a black-box warning on selective serotonin reuptake inhibitors (SSRIs) and selective norepinephrine reuptake inhibitors (SNRIs). The warningfollowed the results of repeated studies indicating that these antidepressantsubclasses increase suicidal tendencies in children and teenagers. Exhibit 10shows the prevalence of antidepressant use in children and adolescentsfor 2003 and the first half of 2004. The data, which reveal decreases ineither prevalence or prevalence growth, signify the beginning of a trendthat continued though the rest of 2004, contributing to the change in overall antidepressant use. Exhibit 10
Change in Antidepressant Use Among Patients Under 20 Years of Age 2003 to 2004
ABSOLUTE CHANGE
QUARTER TO QUARTER
IN PREVALENCE PER
PREVALENCE PER 100 CHILDREN
100 CHILD BENEFICIARIES
Q1 Q2 Q3 Q4 Q1 Q2 Q1
Source: Express Scripts Research — October 2004 Also in 2004, fallout from concerns about the safety of estrogens continued, and estrogen use declined by almost 20%. As a result, theestrogens class dropped out of the top 25 therapy classes. At the sametime, the miscellaneous endocrines class, which includes several drugs used to treat the same conditions as estrogens, grew only 8.8% — a farcry from the explosive growth of more than 20% seen in each of the previous three years. Part of the high miscellaneous endocrines trend inprevious years was due to the inclusion of drugs now considered in thespecialty drug class. However, the relatively low use of these productscompared with other drugs in the class indicated that the majority of thetrend was due to higher use of non-specialty products. Both classes arereturning to more natural utilization rates after estrogens fell dramaticallyout of favor and patients flocked to miscellaneous endocrines for treating osteoporosis.
The fact that 2004 was a “healthier” year than 2003 received much less publicity than OTC releases and safety concerns, but it probably had a bigger impact on overall utilization. Exhibit 11 shows the monthlyPMPY utilization for five classes of drugs that are usually taken to treatacute conditions. Included are antivirals, quinolones and macrolides —three classes in the top 25 for both 2003 and 2004. Antiviral drug patternsare particularly compelling. Consisting of drugs used to treat conditionsas diverse as the flu and HIV, the antivirals saw a large increase for flutreatment in 2003. Flu drugs are typically taken for short durations. In 2004, short-term antiviral drug use was much lower, contributing to the negative 15.3% prevalence change. Quinolones and macrolides,classes used to treat bacterial infections, saw declines of 3.6% and 12.2%,respectively. Decreases in the use of quinolones and macrolides were notoffset by corresponding increases in common first-line antibiotics, suchas cephalosporins or penicillins. In fact, utilization of cephalosporins andpenicillins declined at rates similar to those for other acute drug classes,with respective drops of 7.2% and 11.3%. 22 express scripts drug trend report 2004
Exhibit 11
Changes in the Use of Acute Drug Classes 2003 to 2004
While the trend-management programs detailed in the PharmacyBenefit Guide section of this Report have shown their ability to controlor decrease drug trend, unmanaged trend is expected to continue indouble digits. Our projections for the increases in unmanaged PMPYingredient costs are shown in Exhibit 12. Exhibit 12
Increases in Unmanaged PMPY Cost 2002 to 2004 (Actual), 2005 to 2009 (Projected)
METHODS
The analyses included in the 2004 Drug Trend Report are based on
prescription-drug use for a sample of approximately 3 million unique
individuals, all members of commercial plans that maintained individual
member-eligibility data in both 2003 and 2004. These clients used
Express Scripts for both participating-pharmacy and home-delivery
services. They also offered a funded benefit, meaning that the client
paid at least some portion of the cost for prescriptions dispensed to itsmembers. Medicaid recipients and Medicare beneficiaries receiving drugcoverage through prescription-discount cards are excluded from this studybecause of their unique demographics and drug-coverage policies. About 70% of the resulting 2004 sample consists of nonmanaged-care commercialmembers, and about 30% are members of commercial managed-care plans.
Cost data included in the Trend and Therapy Class Review sections areexpressed on a discounted Average Wholesale Price (AWP) ingredient-costbasis only. AWP is the retail list price of the medication as reported byFirst DataBank. Dispensing fees, administrative fees, member contributionand rebates are not included in the cost calculations. Brand and genericdiscounts are representative of average rates charged across the Express Scriptsbook of business. It should be noted that while all generics are discountedat the same rate in this Report, actual generic discount rates can vary significantly for specific products. Also, in order to eliminate the impact of any changes in discounts from year to year, the same discount percentageswere used in both years. As in previous Reports, prescription counts have been converted to equivalentquantities that would have been dispensed through participating pharmaciesto adjust for differential home-delivery use rates and varying benefitstructures. Drugs sold OTC and prescriptions dispensed in inpatient settingsare not included in this analysis. In a departure from previous years, drugsthat Express Scripts places in the specialty class have been excluded fromthe final calculations. Drugs were categorized into therapy classes — groups of pharmaceuticalagents that are chemically or therapeutically related. Therapy classes were defined by the first two digits of the 14-digit Generic ProductIdentifier (GPI) code maintained by the Facts and Comparisons division of Wolters Kluwer Health. 24 express scripts drug trend report 2004

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